Stage 3 Fontan Operation Liver Ultrasound Study

Noninvasive Detection of Liver Injury Immediately Following the Fontan Operation: the Role of Ultrasound-Based Elastography

The purpose of this study is to compare the liver stiffness, which can be caused by congestion and fibrosis in pediatric patients before and after a Fontan heart operation.

A new form of ultrasound elastography (Acoustic Radiation Force Impulse, or ARFI) will measure liver stiffness.

Study Overview

• Status: Completed
• Conditions: Fontan Operation
• Intervention / Treatment: Device: ARFI Ultrasound

Detailed Description

The Fontan repair for single ventricle congenital heart lesions consists of three stages. This surgery has enable pediatric patients who have the repair to live into adulthood.

Stage 3 of the surgery introduces immediate congestion of blood in the liver by increasing central venous pressure (CVP). CVP is the blood pressure within the vena cava, a major blood vessel in the body.

Many patients later develop progressive liver fibrosis (stiffness) possibly as a result of increased blood pressure. Liver stiffness is increased both by congestion and fibrosis.

Liver fibrosis has significant health risks and may complicate the patient's future healthcare.

There are no established, noninvasive means of detecting the liver fibrosis until it becomes severe. Acoustic radiation force impulse (ARFI) elastography, an ultrasound technique, can measure the stiffness of the liver safely from outside the body.

The investigators hypothesize that liver stiffness will be increased by stage 3 of the Fontan operation due to onset of liver congestion.

Using ARFI, the investigators will measure liver stiffness before and immediately after stage 3 of the Fontan operation, when congestion of blood is likely the only contributor to any change in liver stiffness.

The investigators will follow the trend of liver stiffness at six months by repeating the ARFI imaging.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Pediatric patients ages 0-17
• Patients presenting to the University of Michigan for evaluation just before undergoing stage 3 of the Fontan operation

Exclusion Criteria:

• Patients over the age of 17
• Patients who have chronic liver disease (elevation of ALT, AST, or Bilirubin greater than two times the upper limits of normal >4 weeks)
• Patients who have evidence of liver enlargement or nodularity on prior ultrasound imaging
• Patients who have a history of portal vein or hepatic vein thrombosis
• Patients (parents) who are unwilling to read and sign the informed consent document

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARFI Ultrasound; This study uses ultrasound scanning with acoustic radiation force impulse shear wave velocity imaging to measure pediatric liver fibrosis. Patients will be children who have had the Fontan operation. This is a non-invasive scan that uses sound waves to create images.	Device: ARFI Ultrasound; This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a new ultrasound technology in which unique sound waves create the images/pictures of the liver beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shear Wave Speed (Liver Stiffness)	ARFI shear wave speed measurements were done on the right lobe of the liver. Measurement units are m/s (meters per second). A total of 8 measurements were performed on each subject at each time point.The 8 values were performed on each subject and averaged.	0-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IVC Pressure	Blood pressure in the IVC, the interior vena cava, was measured from a central line placed for patient care.	Baseline and Follow Up Number 1 (approximately 24 -72 hours later)

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Frank W DiPaola, MD, University of Michigan

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: HUM00090329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No